Beschreibung
Senior Regulatory Affairs Manager (m/f/d)
Reference: -en
Start: asap
Duration: 5 MM+
Main tasks:
- Being responsible for regulatory aspects during the development of new VI products (regulatory strategy, applicable standards and guidelines)
- Registration of class III devices in the CE, US, and other highly regulated countries
- Preparation of MDR submission for class III combination products
- Coordinating and submitting deficiency responses to relevant certification bodies and country authorities
- Maintaining regulatory documentation up to date for worldwide regulatory purposes
- Worldwide assessment of changes and support production lifecycles activities
- Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient workflow within the department and project team
Main qualifications
- University degree in natural science, pharmacy, pharmacology, medicine or engineering
- At least profound experience with registrations of class 3 medical devices including drug-device combination products in highly regulated countries, particularly in the CE region and the USA
- Excellent knowledge of the applicable medical device regulations in the countries mentioned above, including current developments (MDR)
- Experience in project management
- Literate in Microsoft Office applications; SAP knowledge is an advantage
- Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously
- Fluency in the English language mandatory, German and any other language an advantage
Main advantages:
- A very renowned company
- Fascinating, innovative environment in an international atmosphere
- Possibility to work remotely
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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